cleanroom validation
Cleanroom Validation
© 2010 Topas GmbH
cleanroom validation
cleanroom applications
laboratories production environments
laminar flow boxes cleanroom concepts
microelectronics
pharmaceutical industry, food industry
nuclear industry, aerospace
polymer industry
surgery rooms initiation!
© 2010 Topas GmbH
cleanroom validation
cleanroom applications
laboratories production environments
laminar flow boxes cleanroom concepts
microelectronics
pharmaceutical industry, food industry
nuclear industry, aerospace
cleanroom cabinet
polymer industry high precision
measuring technique
surgery rooms initiation! M+W Group GmbH
polymer
injection molding
microsystems
production
http://www.grc.nasa.gov/WWW/ictd/content/labmicrofab.html
Krauss Maffei Technologies GmbH
© 2010 Topas GmbH
cleanroom validation
cleanroom design
main objective: reduction of particle number concentrations at sensitive environments
air conditioning (temperature, pressure, humidity) + air filtration (HEPA)
human operator: major particle source special cloths, tools, moving procedures
smoking prohibited 2h before working starts
separation of different working areas with different cleanroom requirements
special locking rooms for operators and materials
definition of a cleanroom
according to ISO 14644:
A cleanroom is an area set apart
by a wall or similar partition, whose
degree of cleanliness is achieved by
purified air ventilation.
Cleanroom environment is pressurized
to outside area.
www.mcko.de
© 2010 Topas GmbH
cleanroom validation
cleanroom design
hospital:
HS-Luftfilterbau GmbH
© 2010 Topas GmbH
cleanroom validation
cleanroom design
microelectronics:
HS-Luftfilterbau GmbH
© 2010 Topas GmbH
cleanroom validation
cleanroom design
turbulent dilution flow unidirectional laminar flow
high flow rate of filtered air vertical flow direction
continuous dilution of particle concentration filtered air circulation
for class 1.000 to 100.000 for class 0,1 to 100
M+W Group GmbH M+W Group GmbH
© 2010 Topas GmbH
cleanroom validation
cleanroom design
laminar flow box / safety cabinets
working places with clean room conditions, especially for laboratory use
economic option to a cleanroom facility
according to EN 12469 standard
Dometic Medical Systems
© 2010 Topas GmbH
cleanroom validation
cleanroom standards
to setup and operate a cleanroom particle measurements are obligatory
from these measurements a cleanroom classification is done according to a related standard
industry contamination standard
Microelectronics particles US Fed 209E ISO 14644
Aerospace particles ECSS-Q-ST-70-01
Food industry microorganism VDI 2083
Pharmaceutical industry bacteria count EG-GMP Annex 1
ISO 14644: most relevant standard: “cleanrooms and associated controlled environment“
© 2010 Topas GmbH
cleanroom validation
cleanroom standards
ISO 14644: most relevant standard: “cleanrooms and associated controlled environment“
by number concentration (particle/m³) of airborne particles.
Annex B describes test method, using an optical particle counter DPC (discrete particle counter)
defines test procedure and validation intervals (6 months ≤ ISO5, 12 months >ISO5)
describes different performance tests
© 2010 Topas GmbH
cleanroom validation
cleanroom standards
ISO 14644: most relevant standard: “cleanrooms and associated controlled environment“
cleanroom classes: particle number concentrations vs. particle size
ISO 3: max. 35 particles/m³ ≥ 0,5µm
US FED 209E
1
10
100
1.000
10.000
100.000
ISO 14644-1: cleanroom classes
© 2010 Topas GmbH
cleanroom validation
cleanroom standards
AMD microelectronics:
production plants
US FED 209E = class 1
max. 10 #/m³ ≥ 0,1µm
testing, assembly
US FED 209E = class 1000
max. 10.000 #/m³ ≥ 0,1µm
© 2010 Topas GmbH
cleanroom validation
steps of cleanroom specification, design, qualification
1. User Requirement Specification (URS) by User
2. Cleanroom and Facility Design by Cleanroom Engineer
3. Design Qualification (DQ) = Commissioning – Procurement
4. Installation Qualification (IQ) = Commissioning – Installation and Testing
5. Operation Qualification (OQ) = Commissioning – Certification
6. Performance Qualification (PQ) = Compliance to Room Data Sheet
7. Cleaning Validation
© 2010 Topas GmbH
cleanroom validation
design qualification (DQ)
to confirm that the designs fit the user required specification
specifications
purchase orders
suppliers proposal documents
layouts
P&ID/flow sheets
contractor strategy / interfaces
installation qualification (IQ)
to demonstrate that the item as installed, conforms to the design specifications
HVAC and other critical instruments are still in calibration
equipment specifications, drawings, operation and maintenance manuals
installation check of critical components
critical component P&ID flow scheme and loop check
testing and balancing report
HEPA filter integrity testing data review
© 2010 Topas GmbH
cleanroom validation
operation qualification (OQ)
to demonstrate that the cleanroom can be operated in conformance to the design specification
HVAC and other critical instruments are still in calibration
testing of critical alarms and interlocks
list of critical operating parameters encompassed by room data sheet
testing for the specifications detailed in the room data sheet
standard operation protocol for HVAC system controls
cleanroom operation protocols for cleanroom operations
performance qualification (PQ)
to demonstrate that the cleanroom can reliably perform according to the design specification
monitoring and testing for particulate levels (surface and airborne)
static particulate monitoring
static microbial monitoring
dynamic particulate monitoring (sterile areas, in operation)
room data sheet is the cleanroom user required specification
© 2010 Topas GmbH
cleanroom validation
performance qualification (PQ)
measurement of air conditions (humidity, temperature)
measurement of static pressure
Filter integrity testing
upstream aerosol generation: adjustment of aerosol concentration to the nominal filter class and the
coincidence concentration of the downstream particle counter
upstream particle measurement: using optical particle counter + dilution system
downstream scanning of the filter: using an isokinetic sampling probe + optical particle counter
determination of air replacement number
Recovery test
generation of test aerosol inside the cleanroom
time measurement to reach 1% of the original generated aerosol concentration
visualization of unidirectional laminar flow profile using a fog or aerosol generator
spatial air velocity distribution below air outlet
determination of flow direction at working space
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
complete equipment for particulate monitoring, filter integrity testing and recovery tests
Aerosol Generator ATM 226
upstream particle generation
Dilution System DIL 554
upstream particle measurement
Optical Particle Counter LAP 340
up-/downstream particle measurement
Isokinetic Sampling Probe SYS 529
downstream particle measurement
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Aerosol Generator ATM 226 upstream particle generation
atomizer aerosol generator
adjustable particle production rate
reliable long-term particle production
designed for mobile use
internal compressor, no compressed air required
integrated mains adapter 100 … 240 VAC
stainless steel housing
designed for clean room applications
7E+6
Concentration, Particle/cm³
6E+6
5E+6 MPPS range
4E+6
3E+6
2E+6
1E+6
0
0 0,2 0,4 0,6 0,8
Particle size, µm
DEHS as a standard test liquid
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Aerosol Generator ATM 226 upstream particle generation
adjustable particle production rate
adjustable generator flow rate for different nominal facility flow rates
different concentrations to test at different filter classes (HEPA, ULPA)
Requested particle concentration in test aerosol, particles/m³
particle concentration
300 x 106 Particle/m 3 400 x 106 Particle/m 3 1000 x 106 Particle/m 3
in total flow
Flow rate Flow rate ATM Flow rate ATM Flow rate ATM
3
Equipment, m /h l/h l/h l/h
50 91 92 98
100 94 96 107
200 100 104 128
300 105 111 150
600 123 136 226
700 130 145 259
800 136 154 296
900 143 164
1000 150 173
1200 164 193
1500 186 226
1600 193 237
1800 209 267
1900 217 281
2000 226 296
2200 243
2500 278
2800 311
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Dilution System DIL 554 upstream particle measurement
required to avoid coincidence errors at the upstream particle counter
“closed” dilution system
no compressed air required
no contaminated exhaust air flow to the cleanroom
small pressure drop
continuous internal monitoring of dilution ratio (1:100)
cascading several units for higher dilution ratio
models for 1cfm or 2cfm particle counters
high HEPA filter capacity (30g)
designed for mobile use
battery operated
stainless steel housing
„open“ dilution „closed“ dilution
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Optical Particle Counter LAP 340 up-/downstream particle measurement
90° light scattering, counting and sizing of discrete airborne particles
designed for mobile use
ISO 14644: photometer vs. particle counter
advantages of using a particle counter:
much smaller upstream concentrations
less filter contamination
much more sensitive to detect smaller leaks
probes: temperature, relative humidity, air velocity, Dp
PC interface for remote control
1)
2)
1) 50% counting efficiency
2) 7,8% coincidence error
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Isokinetic Sampling Probe SYS 529 downstream particle measurement
determination of potential leaks from a filter leakage scan test
validation of each potential leak by a static measurement
isokinetic sampling: sampling with a constant air velocity
0,45 m/s @ 1fcm relates to 1620 (m³/h)/m² specific air volume
accepted tolerance: ± 20 %
rectangular shape 15x80 mm -> exact scanning of filter edges
design / dimensions according to ISO 14644-3
< 8cm/s
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
aerosol generation
Installation and connection of all instruments
ATM 226
starting up the ATM 226, adjusting required
upstream concentration (> 106 #/cf)
DIL 554
upstream concentration measurement, 3x1min
switching the particle counter to the
downstream side, zero counting efficiency
downstream leak scanning test upstream
measurement
N ATM c ATM VATM 1013 P / m³ 0,1 m³ / h
cupstream
Vtotal Vbox VATM 1000 m³ / h 0,1 m³ / h SYS 529 Isokinetic sampling
1000 P / cm ³
LAP 340
10 P / cm ³ (1 : 100 diluted )
c ATM( 0,1µm @100l / h) 107 P / cm3
coincidence concentration of the particle counter: 35 P/cm³
downstream
H14 filter: 99,995% measurement
cdownstream = 0,05 P/cm³ = 1415 P/cf
© 2010 Topas GmbH
cleanroom validation
test software CRQWin
Topas in-house development
in close cooperation with cleanroom service companies to meet their requirements
documented & retraceable cleanroom validation according to ISO 14644, EG-GMP Guideline
Basic protocol data: date of validation, facility operator, facility identification, service company
© 2010 Topas GmbH
cleanroom validation
test software CRQWin
cleanroom specifications: validated room of a facility, room dimension, operation mode at test
nominal cleanroom classification,
specifications of the flow conditions, used HEPA filters
specification of integrated laminar flow boxes
© 2010 Topas GmbH
cleanroom validation
test software CRQWin
used equipment: models of aerosol generator, dilution system, optical particle counter
serial number and calibration data of each instrument
© 2010 Topas GmbH
cleanroom validation
test software CRQWin
cleanroom class validation: particle counts at different measuring positions
average values, standard deviation, 95% confidence interval
confirmation of the nominal cleanroom class
© 2010 Topas GmbH
cleanroom validation
test software CRQWin
recovery test: time dependent static particle measurement
after short-term particle contamination of the cleanroom
by an aerosol generator
© 2010 Topas GmbH
cleanroom validation
Topas cleanroom validation equipment
Condensation Fog Generator CFG 290 flow visualization prototype status
visualisation of flow profiles
leakage detection of filters
leakage detection of cleanroom facilities, e.g. doors
evaporation of a special test liquid at 300°C
rapid condensation when leaving the generator
low impulse, no effect on existing cleanroom flow profile
dense fog, long lifetime
sterile, non-toxic, oil-free fog
designed for mobile use, battery operated
Liquid reservoir 80 ml
Liquid mass flow 1,5 ml/min
Power supply LiPo Akku; 11,2 V, 2,1 Ah
Dimensions 300(700)x70x70 mm
Weight 1,2 kg
© 2010 Topas GmbH
cleanroom validation
reference customers
cleanroom environment & pharmaceutical / semiconductor industry
ABB ASM BAXTER BAYER BÖHRINGER INGELHEIM BROOKS FELCON GM PHARMA LSMW
INFINEON MERCK M+W ZANDER NOVOSIS PHARMASERV QUIMONDA SCHERING SOPHARMA
SERUMWERK DRESDEN THERMO ELECTRON TYCO HEALTHCARE VETTER W.H. MAHL
cleanroom consultants, service companies
C-TEC CAS CCI VON KAHLDEN CLEANTECH SERVICES CLINIX DOHM PHARMACEUTICAL
ENGINEERING INTEGRA REUTEC SG-PLANUNG SKAN AG SOPHARMA
instrumentation for research&development, suppliers
BOSCH BCR CAMFIL-FARR CCS DAIMLER-CRYSLER DEHA DELBAG DUPONT FERRING
FESTO FREUDENBERG ELECTROLUX GRIMM GSF KENDRO HEREAUS KANOMAX KLOTZ
LAVISION LIGHTHOUSE LUWA MAHLE MANNESMANN MANN+HUMMEL MIELE MCLOUD RUSSEL
MEASURETRONIX PMS PHILIPS RESEARCH RIENSCH&HELD TESTO TSI VORWERK
© 2010 Topas GmbH
